Download Mr. Terry A. Yimin CEO/President Essere Corporation Jormet Building

DEPARTMENT
OF HEALTH & HUMAN SERVICES
Public Heiith Service
Food and iDrug Administration
(college, Park, MD 20740
Mr. Terry A. Yimin
CEO/President
EssereCorporation
Jormet Building
Suite 409
4099 William Penn Highway
Monroeville, Pennsylvania 15146
Dear Mr. Yimin:
This is in responseto your letter to the Food and Drug Administration (FDA) dated
July 15,2003 pursuant to 21 U.S.C. 343(r)(6) (section 403(r)(6) ofthe Federal Food, Drug,
and Cosmetic Act (the Act))! Your submission statesthat EssereCorporation is making the
following claims, among others, for the product Flex-Rx Topical Analgesic:
“For external use only.”
“For the temporary relief of minor achesand pains of muscles and joints associated
with simple backache, arthritis, strains, bruises and sprains.”
This product does not appear to meet the statutory definition of a dietary suppleme@
contained in 2 1 U.S.C. 32 1(fQ, and therefore, can not be marketed as a dietary supplement.
We explain the basis for our opinion below.
The term “dietary supplement”is defined in 21 U.S.C. 321(ff). 21 U.S.C. 321(ff) provides
that the term means a product (other than tobacco) intended to supplement the diet that bears
or contains a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary
substancefor use by man to supplement the diet by increasing the total dietary intake, or a
concentrate,metabolite, constituent, extract, or combination of any of the above ~mgredients.
21 U.S.C. 321(ff) further statesthat dietary supplementsare intended for ingestion iin a form
described in 21 U.S.C. 350(c)(l)(B)(‘)1 or in compliance with 21 U.S.C. 35O(c)(l)(B)(ii), are
,not representedas conventional food or as a sole item of a meal or the dietary, and ;arelabeled
as a dietary supplement.
Page 2 --Mr. Terry A. Yimin
An article that is applied externally to the skin is not “intended ~foringestion.” As stated
above, the definition of dietary supplementin 21 U.S.C. 321(fQ statesthat a dietary
supplement is a product “intended for ingestion.” The term “ingestion” has been addressed
by the court in United StatesN. Ten Cartons. Ener-B Nasal Gel, 8% F. Supp. 381; 393-94
(E.D.N.Y.), aJ’d”d72 F.3d 285,(2d Cir. 1995), which states:
The ordinary and plain meaning of the term “ingestion” means to take into the
stomach and gastrointestinal tract by meansof enteral administration. & Stedman’s
Medical Dictionary (4th Lawyer’s Ed. 1976) (defining ingestion as the %&duction
of food and drink into the stomach.“); Webster’s Third New International:&ctionary
(1976) (defining ingestion as “the taking of material (as food) into the digestive
system.“)...
The interpretation of the term “ingestion” to mean enteral administration into the
stomach and gastrointestinal tract is also supported by the language of thei statutory
sections immediatelypreceding and following section 35O(c)(l)(B)(ii). Sec$ion
350(c){ l)(B)(i) states:that the vitamin must be intended for ingestion in tablet, capsule
or liquid form. Each of these forms denotesa method of ingestion that in$@ves
swallowing into the stomach. Section 350(c)(2) statesthat a food is intended for
ingestion in liquid form under section 35O(c)(l)(B)(i) “only if it is formulated in a
fluid carrier and is intended-for ingestion in daily quantities measuredin drops or
similar small units of measure.” This elaboration of “liquid form” also denotes
ingestion by swallowing the fluid.
Therefore, becausethe term “ingestion” means introduced into the gastrointestinal tract, a
product that is applied to externally to the,skin is not subject to,regulation as a dietary
supplementbecauseit is not “intended for ingestion” and is a drug under 21 U.S.C
321(g){ l)(C) becauseit is an article (other than food) intended to affect the structure or
function of the body and under 21 U.S.C. 321(g)(l)(B) becauseit is intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease(i.e., to treat pain associated
with diseasessuch as arthritis and injuries such as sprains, strains, etc.). If you intend to
market this product as a drug, you should contact FDA’s Center for Drug Evaluation and
Research(CDER), Office of Compliance, HFD310, Montrose Metro II, 11919 Rockville
Pike, Rockville, Maryland 20852.
Page 3 - Mr. Terry A. Yimin
Pleasecontact us if we may be of further assistance.
Sincerely yours,
Acti g irector
t..P
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling
I
and Dietary Supplements
Center for Food Safety
and Applied Nutrition
Copies:
FDA, Center for Drug Evaluation and Research,Office of Compliance, HFD-300
FDA, Office of the-AssociateCommissioner for Regulatory Affairs, Office of
Enforcement, HFC-200
FDA, Philadelphia District Office, Compliance Branch, HFR-MA140
8
Dedicated to helping others
through natural skin care,
nutritional and remedy care.
July 15,2003
sser+ Corporation
Jonnethilding- Suite409
4099Wkam&~n!iiihway
Modm&lle,PA15146
(412)3!3-3797
t412)313-26%Fax
Tolf&&66)ESS-EREOt377-3730)
E-mail:[email protected]
www.kssereonline.com
Food and Drug Administration
’
Office of SpecialNulxitional @IFS-%%]
Center for Food Safetyand Applied Nutition
200 c street, SW
Washington,DC 20204
Dear Sirs:
Notice is hereby given pursuant to the requirementsof ‘section 403 ( r
the Federal Food and Drug, and Cckmetic Act and in accordancewith ttxerequwments of 21 CFR
101.93,that EssereCorporation, y.onnetBuilding-Suite 403,4099 William Penn Highway,
Monroeville, PA 15146,within tfie .past30 dayscqenced marketing a Topical Analgesic:bewg
the following statement(s)on the k&I and or l;ibeline;,
WARUlNlR For extemJ u* only. J
e
Avoid contact widt ayes.ffcondiih
worsens or symptoms p&&t for
P
more than 7 daysor re-sopur‘Mhin
a few days, discontinua us* of
productand con@ a doctor.Do not
bandagearaa tightly.
I
.u---mmornm ImwNYIwlfi
Water,Iso~mpanol;Poiyacrylvleinide,
C-13-14lsoparaffin,lauretb 7,~Alo.s.
Lidocaine.Extracts of Arriiea; Rue,
Cbatnomle,EubalyplusOK @w+dia
Extract.TweenSO,Fragraqcce
.-+.irrc.; .’ .,
ESSIRE
conPoRh~lon
t IOLiibsny Avenue -Suite tN7.
Pittsburgh. Pwwytvanis 75222
Phoa*:4tz* 162.210(1
WJ h: 886 . ESS ! EREOI377.$730)
W*6~wmv.earereonlin3om
The undersignedcertifies that the information contied in this notice is complete and accurateand
that EssereCorporation has substitiatf’s that the statementis truthful and not misleading.
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